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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018440
Receipt No. R000021348
Scientific Title Prevention of atherosclerosis by SGLT2 inhibitor; multicenter, randomized controlled study
Date of disclosure of the study information 2015/07/31
Last modified on 2020/07/30

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Basic information
Public title Prevention of atherosclerosis by SGLT2 inhibitor; multicenter, randomized controlled study
Acronym PROTECT
Scientific Title Prevention of atherosclerosis by SGLT2 inhibitor; multicenter, randomized controlled study
Scientific Title:Acronym PROTECT
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the safety and compare arteriosclerosis by intima media thickness (IMT), glucose and lipid metabolism, blood pressure, cardiovascular function among the ipragliflozin group, administrated SGLT-2 (ipragliflozin), and the control group, not administrated SGLT-2.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in mean IMT of common carotid artery from baseline to month 24
Key secondary outcomes 1) Change in mean IMT of carotid bulb and mean IMT of internal carotid artery from baseline to month 24
2) Change in max IMT of common carotid artery, max IMT of carotid bulb, and max IMT of internal carotid artery from baseline to month 24
3) Mean of mean IMT of common carotid artery, carotid bulb, and internal carotid artery, respectively and change in it from baseline to month 24
4) Mean of max IMT of common carotid artery, carotid bulb, and internal carotid artery, respectively and change in it from baseline to month 24
5) Values and change in following items of laboratory test from baseline to month 24
High sensitivity CRP, MDA-LDL, NT-proBNP, high molecular weight adiponectin
6) Values and change in following items of laboratory test from baseline to month 12 and 24
Blood pressure, body weight, BMI, waist circumference visceral fat and subcutaneous fat area (abdominal CT, month 24 only), HbA1c (NGSP), fasting blood glucose, serum lipid [TC, LDL-C (Direct method), HDL-C, TG, Non-HDL-C], AST, ALT, gamma-GTP, uric acid, serum creatinine, eGFR (adjusted value), excretion of urinary albumin (creatinin equivalent)
7) Values and change in following items of cardiovascular function test from baseline to month 24
Echocardiography (LAVI, %EF, LVMI, E/A, DT, E/e', IVCd), FMD, PWV, CAVI, AI

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of ipragliflozin 50 mg once a day pre or post breakfast. When it is insufficiently effective, it can be increased to 100 mg once a day. When it is insufficient effective inspite of increase the dose, it can be added and increased the dose of antidiabetic agents except for SGLT-2 inhibitor.
Interventions/Control_2 In principle, antidiabetic agents should not be added and incresed the dose and diet/exercise therapy and administration of antidiabetic agents except for SGLT-2 are continued during treatment period. However, if it is insufficiently effective, it can be added and increased the dose of antidiabetic agents except for SGLT-2 inhibitor.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Type 2 diabetes with HbA1c (NGSP) >=6.0% and <10.0% nevertheless diet/exercise therapy or diet/exercise therapy adding antidiabetic agents for >=3 months
2) >=20 of age at the time of informed consent acquisition and hospitalization or outpatient
3) The patient provided written informed consent to participate in the study
Key exclusion criteria 1) Type 1 diabetes
2) Has history of severe ketosis, diabetic coma, or precoma within 6 months
3) Has severe infection, serious trauma, or pre or post surgery (including carotid endarterectomy and stent implantation)
4) With severe renal dysfunction (eGRF <45 mL/min/1.73m2 or patient undergoing artificial dialysis)
5) Has history of myocardial infarction, angina, percutaneous transluminal coronary angioplasty, coronary artery bypass graft, cerebral infarction, intracranial hemorrhage, subarachnoid hemorrhage, transient ischemic attacks within 3 months before initiation of the study
6) Heart failure patient whose NYHA functional classification is III or IV
7) Has history of administration of SGLT-2 within 1 month before initiation of the study
8) Pregnant, possibly pregnant, planned to become pregnant or nursing women
9) Has history of hypersensitivity to ipragliflozin or any other excipient of ipragliflozin
10) Are considered not eligible for the study by the attending doctor due to other reasons
Target sample size 480

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Node
Organization Saga University
Division name Department of Cardiovascular Medicine
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga
TEL 0952-34-2364
Email cardiostudy@ml.cc.saga-u.ac.jp

Public contact
Name of contact person
1st name Koichi
Middle name
Last name Node
Organization Saga University
Division name Department of Cardiovascular Medicine
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga
TEL 0952-34-2364
Homepage URL
Email cardiostudy@ml.cc.saga-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Saga University
Institute
Department

Funding Source
Organization Astellas Pharma Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutionnal Review Board,Saga University Hospital
Address 5-1-1 Nabeshima, Saga
Tel 0952-34-3400
Email kenkyu-shinsei@ml.cc.saga-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 jRCTs071180041
Org. issuing International ID_1 Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 佐賀大学(佐賀県)
獨協医科大学(栃木県)
徳島大学(徳島県)
鹿児島大学(鹿児島県)
自治医科大学(栃木県)
長崎大学(長崎県)
北里大学(神奈川県)
広島大学(広島県)
東京医科大学(東京都)
日本医科大学(東京都)
宮崎市郡医師会病院(宮崎県)
佐賀県医療センター好生館(佐賀県)
国際医療福祉大学病院(栃木県)
名古屋第一赤十字病院(愛知県)
防衛医科大学校(埼玉県)
JR広島病院(広島県)
名古屋第二赤十字病院(愛知県)
獨協医科大学埼玉医療センター(埼玉県)
済生会二日市病院(福岡県)
国保旭中央病院(千葉県)
伊万里有田共立病院(佐賀県)
大阪医科大学(大阪府)
医療法人社団旭和会 東京駅センタービルクリニック(東京都)
浦添総合病院(沖縄県)
陣内病院(熊本県)
公立陶生病院(愛知県)
春日井市民病院(愛知県)
福島県立医科大学附属病院(福島県)
名古屋大学(愛知県)
福岡大学病院(福岡県)
済生会福島病院(福島県)
済生会熊本病院(熊本県)
名古屋市立大学病院(愛知県)
大阪市立大学(大阪府)
横浜南共済病院(神奈川県)
産業医科大学(福岡県)
和歌山県立医科大学(和歌山県)
会津中央病院(福島県)
土井内科胃腸科医院(熊本県)
国立循環器病研究センター(大阪府)
羽生総合病院(埼玉県)
慶應義塾大学(東京都)
兵庫医科大学(兵庫県)
東京女子医科大学(東京都)
筑波大学(茨城県)
太田綜合病院附属西ノ内病院(福島県)
琉球大学(沖縄県)

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 479
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2015 Year 05 Month 21 Day
Date of IRB
2015 Year 06 Month 01 Day
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 07 Month 27 Day
Last modified on
2020 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021348

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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